论文部分内容阅读
目的建立中药复方制剂扶正平消胶囊的定性定量方法,为完善其质量标准提供科学依据。方法采用TLC法对扶正平消胶囊中的主要成分龙胆苦苷、贝母素甲、黄芪甲苷、狼毒进行定性鉴别;采用HPLC法对扶正平消胶囊中的血竭素进行定量分析,色谱柱为Agilent ZORBAX Eclipse XDB-C_(18)(250mm×4.6mm,5.0μm),柱温:40℃;流动相为乙腈-0.05mol·L~(-1)磷酸二氢钠水溶液(60∶40),流速:1.0ml·min~(-1),检测波长:440nm。结果 TLC鉴别中龙胆苦苷、贝母素甲、黄芪甲苷及狼毒的斑点清晰,阴性样品无干扰;血竭素在0.7761~49.67μg·ml-1范围内线性关系良好(r=0.9999),最低定量限为0.7761μg·ml~(-1),重复性、稳定性试验结果的RSD均<3%,加样回收率的平均值为103.5%,RSD<1.5%。结论本研究建立的方法进一步提升了扶正平消胶囊原有的质量标准,可实现对扶正平消胶囊的质量控制。
Objective To establish a qualitative and quantitative method for Chinese medicine compound prescription Fuzheng Pingxiao Capsule to provide a scientific basis for improving its quality standard. Methods The main constituents of Fuzheng Pingxiao Capsules were identified by TLC. Genistein, Fritillaria, Astragaloside, and Stellera chamaejasme were identified qualitatively. The content of Dracorhodin in Fuzheng Pingxiao capsule was quantitatively analyzed by HPLC. The column was Agilent ZORBAX Eclipse XDB-C 18 (250 mm × 4.6 mm, 5.0 μm) with a column temperature of 40 ° C and a mobile phase of acetonitrile-0.05 mol·L -1 sodium phosphate monobasic (60: 40), flow rate: 1.0 ml · min -1, detection wavelength: 440 nm. Results The spots of gentiopicroside, fenugreek seed A, astragaloside and chamaejasme were clear and negative in TLC. There was a good linear relationship between the concentration of dracorhodin and 0.7761 ~ 49.67 μg · ml-1 (r = 0.9999 ). The lowest limit of quantification was 0.7761μg · ml -1. The repeatability and stability test showed that all the RSDs were less than 3%. The average recoveries were 103.5% and RSD <1.5%. Conclusion The method established in this study further enhances the original quality standard of Fuzheng Pingxiao Capsule and realizes the quality control of Fuzheng Pingxiao Capsule.